BIOACTIL- pain relieving gel 
POLIMEROS Y SERVICIOS S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Submission for Bioactil Pain Relieving Gel

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BIOACTIL 
pain relieving gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69492-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ORTHOSILICIC ACID (UNII: 623B93YABH)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69492-013-071 in 1 BOX03/12/2019
170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/12/2019
Labeler - POLIMEROS Y SERVICIOS S.A. (815740251)
Establishment
NameAddressID/FEIBusiness Operations
POLIMEROS Y SERVICIOS S.A.815740251manufacture(69492-013)

Revised: 3/2019
Document Id: f0e928b1-0393-415d-a74f-4620538c219a
Set id: 744d7c69-6095-4d47-8f92-b685bf5ad00e
Version: 2
Effective Time: 20190313
 
POLIMEROS Y SERVICIOS S.A.